Position: Process Validation Project Manager

Location: On Site - San Francisco Bay Area
Employment Type: Contract
Direct Reports: No

Salary Range: $50 - $75 Hourly

Company Overview:

Founded in 2002, Enterey brings a wide range of consulting expertise to our clients in the Life Sciences Industry. We partner with our clients to help them reduce risk, operate more efficiently, and focus on what they do best - delivering safer, more effective products and treatments for their patients. We show uncompromised commitment to excellence while delivering high-quality, tangible solutions, in support of our primary goal of client satisfaction.

Client Overview:

Our client is a global leader in the biotechnology industry, developing and producing biologic drugs to treat serious medical diseases. They offer products to aid in the diagnosis and monitoring of various medical conditions, as well as offering programs to assist patients with access and reimbursement for treatments. They prioritize diversity and inclusion and foster a belonging in their work environment and community.

Position Summary:

The Process Validation Project Manager (PV PM) role will provide support to Technical Development Teams (TDTs) on Process Validation (PV) including project and portfolio analyses and communication of key insights to inform decision-making. The PV PM will work closely with PV stakeholders to plan, maintain, and manage all PV deliverables. The role will be a part of the Project and Portfolio Management function.

Travel Requirements:

None

Essential Duties & Responsibilities:

• Support the TDTs and ensure on-time Market Applications (MAs) by developing and maintaining PV project schedules and dashboards to track progress. Enhance functionality and presentation of system templates based on user feedback and identified bugs.
• Apply drug/CMC process development knowledge and project management expertise to manage PV deliverables for multiple projects through MA filing and Pre-Licensure Inspection (PLI).
• Lead regular meetings with PV leads to ensure PV studies are on track and keep all relevant stakeholders including the Technical Development Leader (TDL) updated on PV project status, key risks and issues.
• Provide expertise and guidance to TDTs on PV at project level including continuous improvement of business processes and tools analyses and communication of key portfolio insights to inform decision-making.
• Act as a valuable member of the overall project team system (e.g., shares best practices and lessons learned).

Position Requirements:

• BS/BA degree in scientific field.
• 2 years in the pharmaceutical/biotech industry.
• 2 years drug development project management and process validation experience are preferred.
• Experience and knowledge with Smartsheet, Tableau, and other reporting and tracking tools.

Knowledge/Skills/Competencies:

• Knowledge of the drug development process.
• Knowledge and experience with end-to end CMC process development; relevant process validation, regulatory, quality and cGMP expertise is preferred.
• Ability to manage cross-functional teams and development projects and to apply project management skills, methodologies and tools.
• Strong collaborative and relationship-building skills; demonstrated ability to effectively partner and influence internal and external stakeholders.
• Excellent verbal and written communication skills; must be able to effectively communicate/articulate strategy and deliverables to team members and senior management.

Benefits:

Benefits stipend offered after eligibility period (provided minimum eligibility hours are met).
401K eligible upon hire, including company contribution.

Qualified applications with a criminal history will be considered for employment.

Visit www.enterey.com to review case studies of sample projects.